Understanding Medical Device Quality Systems & FDA QMSR Impacts: What they don't teach you at work

Starts:  Jul 9, 2024 08:00 AM (CT)
Ends:  Jul 10, 2024 05:00 PM (CT)
Associated with  Medical Device Division

Biomedical manufacturers and their suppliers rely on an effective quality management system to ensure they produce safe and effective products and comply with numerous regulatory requirements.  Despite the critical importance of the quality management system, many working for these companies have had little or no formal training.  Or, training only focuses on presenting what the regulations and standards state without explaining their intent.  What about the impacts of the FDA’s new Quality Management System Regulation (QMSR) referencing ISO 13485?

This two-day information-packed class fills that gap by explaining what a quality system is and its real intent, the history of the regulations and standards that define the requirements, what those requirements are, and what they mean.  This class will be particularly beneficial for those who typically only get to work within a small part of their company’s quality management system.  However, those in the industry for a long time in many roles may also be surprised by what they hear and learn in this class as the instructor provides a clearer view of the entire system.

Audience: Anyone who works for a medical device-related organization with either no or minimal knowledge/experience or no formal training in quality management system requirements.  This includes anyone trying to determine the impacts of the FDA’s new Quality Management System Regulation (QMSR), which focuses on ISO 13485.

Day 1

·        History of Quality, Standards, Regulations, and the FDA

o   How did we get here?

·        Quality System Basic Concepts & Intents

o   What is Quality and why is it a system?

·        Management Responsibility

o   Why does leadership matter to quality?

·        Resource Management

o   Are training and competency the same thing?

o   You need more resources than just people

·        Documents & Records

o   What’s the difference and how do you produce good ones?

Day 2

·        Design Controls

o   What is it and when does it really begin?

·        Production & Process Controls

o   Wait, there are more processes than just production?

·        Purchasing & Supplier Management

o   This isn’t the same as shopping

·        Control of Nonconforming Product

o   “Product” might not mean what you think it does.

·        Customer Feedback

o   Not just complaints?

·        Audits

o   What are internal audits supposed to be for, and what happens in an external audit?

·        CAPA

o   Why is this so important and why do manufacturers keep getting it wrong?

Information & Registration:  https://mp.gg/ey8cbu9wmj

Certificates of Completion: Issued via email, after workshop completion, for 2.0 ASQ RUs or 2.0 CEUs.

If you have any questions, please contact Karen Peifer at kdpeifer@memberleader.asq.org.


Steve Gompertz (CQM, CBA, RAC-US, CMII) is a leader in Quality Systems management with over 25 years of experience in the life-science industry.  His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican BioThermal, St. Jude Medical (now Abbott), Boston Scientific, Medtronic, Vital Images, and Control Data.  He is now a consultant to the industry providing guidance on quality systems and regulatory compliance.

Steve holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, biomedical auditing, regulatory affairs, project management, and configuration management.  Steve started his professional career in software development and then moved into systems implementation project management.  After joining the medical device industry, he transitioned from implementing quality-related IT solutions to managing quality organizations and processes.  Steve also helped St. Cloud State University develop and is a Sr. Adjunct Instructor in M.S. in its Medical Technology Quality program.  Steve can be reached at Steve.Gompertz@QrxPartners.com, and more information about his experience is available at https://www.linkedin.com/in/stevegompertz/

Sponsor Information:

The MN ASQ Biomedical Consortium (BMC) is a group of quality professionals promoting and advancing quality tools, principles, and practices through educational events.  We focus on the medical device industry but promote events for other regulated environments.  As an active member, you can attend BMC events for free!

·         Follow us on LinkedIn to stay informed of upcoming events:  https://www.linkedin.com/showcase/90642322/

 To become a member of the MN ASQ Biomedical Consortium, please contact Karen Peifer at kdpeifer@memberleader.asq.org.

The American Society for Quality (ASQ), Medical Device Division (MDD) enables and elevates quality professionals in the medical device industry by providing thought leadership, education, collaboration networking, and leadership opportunities and by nurturing professional development. MDD is dedicated to elevating industry standards and driving continuous improvement to make a lasting impact on the medical device industry and the lives it touches.

Join our community or contact us for more information at: asqmddiv@divisions.asq.org

The American Society for Quality (ASQ), is a knowledge-based global community of quality professionals, with nearly 80,000 members dedicated to promoting and advancing quality tools, principles, and practices in their workplaces and communities.  As your career partner, ASQ membership benefits are designed to help meet your growing needs as a quality professional.  Membership provides exclusive access to quality knowledge, solutions, and resources to solve challenges, and skill development to advance your career. ASQ is committed to providing enhanced expertise, professional networks, tools, and solutions to help our members advance their products, services, and industries.

ASQ:  https://www.asq.org/ 


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